← The AOFAS Orthopod-Cast
The AOFAS Orthopod-Cast
Bone Infection Management Tools You Should Know. Sponsored by BONESUPPORT™
00:49:21
This episode is sponsored by BONESUPPORT™, makers of CERAMENT® G with Gentamicin – the one and only FDA authorized, antibiotic-eluting bone void filler. For more information, visit Kent Ellington, MD, from OrthoCarolina, moderates a...
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- [00:01]
A
Welcome to AOFAS Ortho Podcast, where leaders in foot and ankle orthopedic surgery discuss the issues that affect you and your practice. Please note that the views expressed on this podcast do not necessarily represent the views of the AOFAS or its members.
- [00:27]
B
Welcome to this AOFAS industry session sponsored by Bonesupport. We would like to thank them for their support of the American Orthopedic Foot and Ankle Society.
- [00:37]
C
This is an orthopedic expert discussion on the use of Bonesupport's product, Ceramint G. Some of the uses discussed here may not be approved or cleared by fda. The experts are independent and the content is not in any way influenced by bone Support. For complete product information, including indications, contraindications, warnings, precautions and potential adverse events, see package insert.
- [01:04]
B
Hello everyone. Welcome to the AOFAS Podcast sponsored by Bone Support. My name is Kent Dallington. I'm an orthopedic surgeon in Charlotte, North Carolina at the Ortho Carolina Foot and Ankle Institute. I've been in practice for 15 years and have a extensive history with bone support using Cerament G for my patients with great success. It's been an amazing product in my practice and no pun on words, but filled a great void in my practice. Specifically. I have the great honor of being the moderator today for this podcast and we have the distinguished guest of Dr. Chris Krulin and Dr. Victor Anciano to join us tonight and I'll let them introduce themselves.
- [01:49]
D
All right, well my name is Chris Krulin. I'm out here in Sacramento, California at UC Davis and I've been practicing for 14 years and like Kent, Sarah McGee has kind of come in and really done a big job in managing infection, managing limb salvage, and really helped changing the algorithm and how we approach a lot of the difficult problems that I think in the past the probably quicker to jump to amputation and now we have a lot more options to try to keep limbs on some of our patients.
- [02:22]
E
Great, thanks. And this is Victor Anciano. I'm an orthopedic surgeon out of the University of Louisville Health in Louisville, Kentucky. Very happy to be here and thank you guys for joining us. I've been in practice for four years, starting my fifth year now, and I've made a little niche for myself where I really enjoy limb salvage and that's how I got to know Saruman, started working with Saruman and helping save some limbs and as Dr. Krullin said, not jump into amputations right away.
- [02:50]
B
Awesome. Thanks guys and thanks for contributing to the podcast. I'm going to start out with a little bit of introduction on the product and then after that we'll go into a couple papers that we have reviewed and, and discuss them in kind of an open forum and then we'll wrap it up. So first of all, you know, people want to know what is Ceramen G? Exactly. And so Cerament G is a injectable synthetic bone void filler consisting of 40% hydroxyapatite and 60% of calcium sulfate and then obviously the antibiotic gentamicin sulfate. What's interesting is the unique ratio of hydroxyapatite and calcium sulfate is designed to enable cerament to resorb at the same rate that the bone forms the breakdown. That percentage breakdown is obviously scientifically based. Calcium sulfate acts as a resorbable carrier for the hydroxyapatite. Hydroxyapatite is highly osteoconductive, promoting bone growth. The addition of gentamicin obviously protects against colonization of gentamicin sensitive microorganisms, which is basically most of them. The characteristics of Sarament G mean that the surgeon can manage both the bone defect and a more patient friendly and specifically single stage procedure. Oftentimes, Seromet G has many proven clinical outcomes, many studies with the lowest refracture and reinfection rates of any synthetic bone substitute on the market, and allows us to move to a single stage from a multi stage surgical protocol which then obviously frees healthcare resources to meet other needs and helps patients get through their particular problem, injury or infection faster. This is obviously more cost effective to the hospital systems and healthcare systems in general. It remodels into host bone within 6 to 12 months. Ceramic G is injectable and flowable and you can kind of tailor that based on how long you wait after you mix it on the back table. And the gentamicin elution is above the MIC and it's reliable, consistent and very high dose in a very beginning. And then this sustains itself for weeks after implantation, making sure that you're able to really eradicate the infection. It's important to note that even though you have a high MIC locally, there's not any type of high serum gentamicin levels that can create potential problems that we know gentamicin can do. So it stays local. They have proof on that. We don't have to worry about ototoxicity or nephrotoxicity. With that introduction and our understanding of the product, US three have widely adopted its use in our or specifically for the treatment of open fractures prophylactically when we are treating the fracture or nailing the fracture. And in addition, using ceramen G to treat active infections, specifically osteomyelitis, and definitely in patients with comorbidities such as smoking, diabetes, vascular disease, et cetera, where peripheral blood flow is compromised. And so you can give the patient all the antibiotics you want in their iv. And but if you don't have a local high dose concentration antibiotic delivery locally, then those bacteria are never going to see the antibiotics that are giving through, you know, PO or iv and thus you have recurrent infection. And so local delivery of cerement G or gentamicin through serum and G allows us to, to really, you know, kill the bugs that are causing these problems for us. And so, you know, so why do I use it specifically is those main indications? And so osteomyelitis and fracture related infections are the two main reasons. First we're going to talk about two studies and then go into some case based discussion. The studies are going to revolve around a paper by Dr. McNally talking about the treatment of acute infection and osteomyelitis treatment with mid to long term follow up and then another study with pomeroy and also McNally talking about the use of cerement G with intramedullary nailing of open fractures and infected nonunions. I'm going to rely on Dr. Kruelin and Dr. Anciano to share their thoughts about the study and then we can have a discussion about them and chat up how we take this study and incorporate it into our practice. So first we're going to talk about about Dr. McNally's study and he did an incredible paper that was published in JBJS in 2022 and it looked at 100 patients with osteomyelitis and it was mid to long term follow up of single stage surgery, four patients that had chronic osteomyelitis using ceramic G. And it was prospective and the mean follow up was six years. And so that's just, you know, incredible. So many orthopedic studies are how they're doing at one year and two years. So I applaud McNally and the team to perform a robust and long term study here. And so I'll start with Dr. Krulin and just kind of thinking about this paper in general. Any specific thoughts from a kind of high level view and then we can kind of get in some details and we'll kind of go back and forth between Dr. Krulan and Dr. Anciano yeah.
- [08:37]
D
Thank you, Kent. The group at the Nuffield Orthopedic center in Oxford is an amazing group. I actually had the honor to go out there this past February and see how everything goes there. They have their own institute. They're basically the main game in town for the national healthcare system in England. So all these infections come to them, have follow up with them, so they can just do amazing research and they have an amazing data group collecting all this data and they're just constantly busy, constantly getting new people in. And their clinic is amazing. I think the big thing that you kind of see in the paper and you might overlook in when we're reading it in America is they have basically a triple visit. So they have infectious disease, the orthopedic surgeons and the infectious disease people all working as a team together when they're analyzing these patients. And so that's why they can have such a great algorithm and maintain such a strict protocol when they're seeing their patients. So the things that stand out for me on this paper is the first part is that they made sure they're in this single stage, that not only did they debride all of the infection, all the infected bone, but they then if the bone was stable, they would just fill it with cerument and then be done. But every now and then they had to use either internal or external fixation. And regardless of that, I think the most important thing that they did was made sure that they had soft tissue coverage. And that meant that once they were done, the plastic surgeon was waiting. They have one plastic surgeon, he's amazing, and he would come in and he does muscle flaps with a split thickness skin graft and he compresses them right away to get that swelling out so that we got to see patients. And it didn't even look like they had a flap. It was quite amazing. But the key there was communication between plastics and the orthopods and then it was all done in one case, in one visit to the operating room. Instead of leaving them in a wound vac, then having plastic surgery come and maybe getting a big huge flap that doesn't have a good cosmetic look. So I think that's the big key. Like you said, the numbers were great, but also that they just have a very good protocol. And I think it's something that we here in the States, a lot of institutions around here probably could work on improving that protocol based on what they're doing. And the other part of it is that you're using a high dose gentamicin so you talked about that in your introduction. But the gentamicin levels are way above the mics. And so really, even a bug that might be gentamicin resistant at the mics most likely is not gentamicin resistant at these high doses. And that's what Dr. McNally will talk about whenever you talk to him, too. So I thought it was a great paper. I think it's something that we can really work on here as we kind of improve our protocols now that we have the ability to use ceramic G here in America.
- [11:53]
E
Yeah, I agree. I thought the paper and the way that they set up their protocols is fantastic. I mean, if you go back to the original Gustillo papers of open fractures for 3B and 3C, their infection rate was as high as like, 45 to 52% for this fractures. And even after they started advocating for immediate antibiotic, immediate debridement and local delivery of antibiotics that started later, some of the papers for that still quote anywhere to as low as 5% to as high as 40%. So it's a little bit all around. And I think we're still working on trying to find a good way to control that initial load of bacteria to the bone. So having them do this and shows that in a single stage, it's possible to do that, I think 6% recurrence rate, it's pretty fantastic for this kind of bad problems. The other interesting thing would have been nice to see as well is just they talked a little bit about the six patients that had recurrence of the infection. And it kind of alludes to the fact that, like, none of them were kind of related to patient comorbidities and most likely probably soft tissue issues. And that's something to understand with this fractures as well. Right. Sometimes you can. If you don't have good soft tissue coverage, there's not a lot that you can do. And I'm assuming that some of those patients fell into that category. But whenever the soft tissues press in there, I think cerumen is a great option for single stage management.
- [13:17]
B
And yeah, Chris, I'm glad you brought up the system. I haven't been there. That's really cool. You've been there. I have met him in person here in the States, and when I learned about how they did things, that definitely leads their success. It's really cool to see a team approach to this, and it's what it needs because, you know, when we take care of these patients here, it's ied, it's vascular, it's plastics if this poorly controlled diabetic, sometimes endocrinology. And then there's shoes and prosthesis and all this, you know, orthotics and things to try to prevent future skin breakdown and ulceration. And some of these patients get lost to follow up. They have poor resources, they have bad social situations. And being able to have a team approach and tackle this, hit it hard with the single high dose of gentamic in single stage with such incredible success rates, To Victor's point, only 6% had a problem with 100 patients in 6 years. Follow up as average is just tremendous. And so there's a lot to learn from this. Obviously Seromet G is a great local antibiotic, bone void filler and antibiotic delivery. But to y' all's point, we can learn how to, you know, replicate this system at some degree here in the States to improve our care for our patients.
- [14:38]
E
Kent, I'm glad that you're bringing it up and focusing as well on the team approach and Dr. Krulin as well, because I feel like we've done some of these presentations for sermon and some people that haven't heard about this. I feel like sometimes there's either a disbelief or just an idea that this is a magic wand and that this is the answer to things. And I think something that's important to to transmit to everyone is that this is just a very powerful tool. But the basics of what we do, the basics of surgery, patient care, multimodal approach to the patient, that's are all very important. And I think this paper really focuses on that too, which is exactly as you guys are saying. Having a vascular team available, having your ID folks available, making sure you're falling and all that, because just a single time Breedman with antibiotics alone is not going to take care of it. It's just a matter of having a team as well there. So I always emphasize everyone making sure that this is a great tool to have, but the basic principles of debridement and antibiotic should be considered as well.
- [15:37]
D
Yeah, I think one other thing to note is if you look through the methods, they discuss the use of oral and intravenous antibiotics and there have been a couple studies that have shown that with high dose local antibiotics such as ceramic G, the need for local antibiotics or for IV antibiotics or even oral antibiotics diminishes significantly. They're now working on studies that will show without implants. So if you leave hardware in there, they're still not sure. You can just rely on gentamicin. Cement. But you can clean this out if it's a stable clean out and the bone is stable. A lot of times what they do is they'll admit the patient for a day or two, make sure the bug is susceptible to gentamicin, and then if it is, they stop the oral antibiotics. If it's not, they usually put them on an oral antibiotic. If there's an implant there, an intramedullary nail, a plate, something like that, then there's discussion about do you need IV antibiotics or if they're resistant to the gentamicin. But I think that's a big algorithm change. And this was the first paper, and there's more to come. I think another one came in 2024. Just looking at how this decreases the need for ongoing antibiotics as well, which I think really makes it easy for patients that they don't have to worry about home health and all of that stuff that our clinic has to coordinate. And a lot of times they don't necessarily have the resources to do that. So this has been a good agent to help manage infection in that way as well.
- [17:10]
E
And you mentioned for antibiotics as an outpatient and home health, and this is, you know, a paper out of the UK and our American population can be a little bit different, especially in particular sectors of the U.S. so one of the main hospitals I work at, we just have a very high morbidity for patients, and I deal with a lot of chronic kidney disease. So when you first mentioned the systemic dose of gentamicin from serumin G being so low that that you can't really see it or it doesn't really affect organs, it's very important for us too, because the types of patients that we have are very susceptible to that. And sometimes we cannot give them the antibiotics we want to because of either their dialysis schedule or their chronic kidney disease. So this comes into play for that.
- [17:57]
B
Yeah, I think that's both of those really important points to emphasize. And to Victor's point, so many of these patients have systemic disease. And we definitely have taken care of patients that need a certain antibiotic and you can't give it to them because of their kidneys or other issues. And it's nice to know, like, okay, well, we can't give them that antibiotic they need, but I know I got ceramic G hanging out in their tibia and doing what it needs to do locally. And to Chris's point, you know, there's off of PO antibiotics and Piclon antibiotics earlier than the typical six weeks or more that we're used to that's in a tremendous health care savings. There's complications with taking PO antibiotics and IV antibiotics long term. Whether it's, you know, GI disturbances, screwing up your own microflora. There's the bigger, broader picture, epidemiology, you know, are we creating antibiotic resistance in the community when these patients are taking long term PO or IV antibiotics. So it's great to be able to have. And to Chris's point, you have a cleaned out bone, you don't have retained hardware. Getting these people off of systemic antibiotics earlier, tremendous advantage and something that's probably, I think is overlooked a lot with the use of serum and G. I.
- [19:15]
E
Was going to comment as well for the management of fractures that it's nice as well to not have, you know, your typical PMMA cement. That's in the way of your X ray, in the way of your hardware. Things that you may have to consider to go back in there and take out again. So that's another part as well that for me it plays a big role where I know that I don't have to come back for it. I know that it's just there to eventually bone to grow into it as well, versus having to come take it out.
- [19:43]
B
Yeah, great point. That's an excellent segue into our next paper. So I hope the audience has a good understanding that in this paper is 100 patients with chronic osteomyelitis. The long term follow up with 94% plus success rate and then eradicating the infection. And you know, a lot of these patients, if you don't get their infection removed, a lot of times it can lead to some type of either partial foot or below knee amputation. So this is truly limb salvage type of technology here. And segueing into the fracture paper that Dr. Anciano just mentioned here is a paper in the Journal of Orthopedic Science and research in 2024. So fresh off the press from last year with Pomeroy and McNally as well, looking at the use of intramedullary nailing with cerament G and talking about their experience and results using that they call it INAC or nac. Intramedullary narrowing of absorbable antibiotic carrier. We went with Prulin on the intro for the first paper. We'll have Dr. Anciano kind of start us off with this paper. And again, what it's doing is it's looking at the use of coating the intramedullary nail with cerament G and also injecting ceramic G into the reamed medullary canal before placing the titanium nail. So I'll let Victor kind of start us off with that.
- [21:13]
D
Yeah.
- [21:14]
E
So I really like this paper because it kind of validated a few of the things that I have been doing. Made me feel like I'm not alone in the world dealing with this complex patients and ways to manage this. So very frustrating way of doing antibiotic cement for our nails. In the past, having a hard time trying to coat the nail, trying to find tubes that fit around the nail that we can fill with cement, trying to find ways that we can mold it with our hands. Feel like everyone has their own techniques to get those PMMA cement around the nail and, and cerumen just really provided an excellent option for this. So they talk a little bit about their technique and after they've done their reaming for their intramedullary nail, they used, they mentioned about 5 mils for tibias and femurs and just use the injector that they have to put it inside of the bone and fill it with the cerements and then they just pass the nail through it and that coats entire nail. So now you have coating around the nail and at the side of your fracture ready to receive that without having to do any previous molding for it. So it's a great technique and I think, you know, we can maybe start talking about the toucan as well. Maybe we'll touch base on that later because another way to do this is with the new cannula that's out there as well, which is called the toucan. And it's very helpful to get the cement injected into the canal before reaming. But to me at least this has changed my practice completely. I used to do the antibody coated nails which had a lot of issues not just with preparation of the nail, insertion of the nail and then taking the nail out, but you know, it just added hours in the operating room and multiple procedures versus now not only can you go back to a single stage procedure where you're using the adequate size of the nail that you want, but you're also knowing that you have that deliver of antibiotic that's going to stay there. Not only does it help the bone, but then you're also providing antibiotic delivery for several weeks. So to me this really kind of changed my practice and I adopted this early on and have only done this since then without any issues or going back.
- [23:28]
D
Yeah, I think this is a good article. You know, I think it's. I don't have to take call, thankfully. But. So the open fracture stuff. But for our trauma guys, this has really been important or for people who are on call when you have an open fracture and you want to reduce that risk, you know, they had a minimum one year follow up and 91% were infection free. And. And then they had basically, you know, one from the infection group and one from the high risk group with recurrence for infection. I think another point to make is making sure, if you look at the technique, making sure you're taking enough samples when you already have infection, again being there and seeing it, they're very particular about it where they use a separate forceps and a separate scalpel for each specimen that they take and nobody's touching the specimen cup. So they have five separate and then they send three specimens to histology and that helps them see how active the infection is. But a lot of times that helps with. If you have, let's say you have four negatives and one positive in your specimen samples and you kind of wonder if it's negative or positive. If there's no PMNs or inflammatory cells in the histology findings, then that's probably a contaminant. And those kinds of things help sort out what you're doing and how you can direct your care long term. I think yeah. The key here is that now you don't have to create the nail like Victor was saying. You can just put a nail and have standard mechanical stability of the bone and have the fracture reduced and you have that cement there that doesn't leak away and it stays there and helps dilute over 28 days to really fight off any infection. And I think the evidence is here. And again they have great follow up.
- [25:28]
E
Yeah. One of the things I noticed from them and we noticed this in practice a lot and I think that people should know it if they don't have a lot of experience with cerement. If you're doing it for open fractures or infections, osteomyelitis with any open wounds in the area, they talk about this leakage problem and it's. It is very common. They mentioned about 5 to 10%, I believe, of their pictures. I feel like I see it a fair amount as well. And if you are not looking for it or don't know what it is, a lot of times it can be confused with their spirulence coming out from the wound and people get worried about it. The patient calls in their strainage and then when you see it in clinic, it's just cerumen that's eluded a little bit out of that area, so it's not something to worry about. But it does happen. And it has that chalky consistency of cerements. So once you see it, you'll know exactly what it is. But also important to just call attention to it. So you know, when you're following up this patient, you don't worry about that leakage because it's there. It hasn't affected wound healing, at least it hasn't for me. But sometimes it's present. It can be scary for the patient.
- [26:33]
D
I think one technique point that this paper, I don't know if they really talk about it, but when you're injecting to insert a nail, whether using the toucan or one of the cannulas that they provide in the kit, I think it's important to remember that you gotta put it into the canal a little earlier, you know, one to two minutes, where it's a little soupier, a little looser, because if you wait too long, it makes the fit of the nail a little too tight and can be kind of difficult to mallet the nail or sink the nail, whether it's a hind foot or a tibia or whatever you're doing. And so by having it in there a little bit on an earlier stage, a few minutes after mixing, it allows that nail to slide up. And that will also, you know, help the coating. If we go back to the first article where they debrided, let's say you open up and you have a big hole in the distal tibia or the calcaneus, and you have a big area. The technique there is to try to dry that area out as much as possible. And then you want to sit on the cerumen, leave it in the syringe a little longer, maybe five, six, seven minutes. Do a little test. We like to say it let it look a little bit like toothpaste. So it starts to dull, you don't have that shiny look. And then inject it into that area and maybe just compress it a little with a 4x4 or a lap and hold it and then don't touch it. And this is the point where it kind of gets hard in a nail. You slide it up and you keep working. But if you're feeling a defect, you got to kind of sit and wait and let that defect, the ceremon, harden a little bit before you move on. So it might take you 10 minutes or something. And. And that's difficult to, to wait on. But those are the technique pearls I think that I've gained and I learned reinforced when I was in Oxford. But those are the things that really help you be effective in using this and optimizing Ceremon.
- [28:35]
E
Yeah. Chris, tell me if you do any of this with tourniquet. I usually do all my nailing without tourniquet, but I found that whenever I'm doing ceremen, I do bring the tourniquet up just like prior to mixing and just hold it there. And then after application, once my nails in, I bring tourniquet back out. I've just found that it helps a little bit as well with keeping all that cement in there without too much bleeding out. But I know it's a preference thing, but for me it has been nice and easy to reproduce.
- [29:03]
D
Yeah, tourniquet everything, so. But I agree, you know, getting all that blood in there will kind of make it a little more loose and it will move around. And so in, in somewhere where you're trying to fill the defect and have it sit, it's probably going to complicate things or make it a little more difficult. So I think putting the tourniquet up in your case is the right call. Sometimes what people will do is you create a separate drill hole. You know, the silo technique is discussed and you have multiple drill holes. And in one of those drill holes, you put a Fraser tip in there and that can help suck all the fluid out. And then you can fill all the other holes with cerumen and they will set a lot easier because you're getting the fluid sucked out through another hole. I recently used that technique on a distal tibia when I was revising an infected pilon fracture to a fusion.
- [29:55]
E
Yeah, I think sometimes when you're putting this on, you can see some of it on X ray, which is nice. You don't really necessarily need to have the canal be completely filled with cerements. You may not notice it when it's that faint on the floral machine, but it's always very satisfying when you put the whole ceramic in the canal. And then as you're passing your nail, you're always kind of worried a little bit. It's like, well, I hope it's coating the whole thing. And then if you're working with open fractures, if you're working with non unions or malunions that are infected, when you pass your nail, you start seeing your serum and looted from all those open areas of the bone that are more distal to where you're inserting the nail. So it is really rewarding to see that because that kind of puts you at ease that it is coating the whole nail and it's getting through the entire bone. It's not just that the area where you're inserting, where you're putting in the.
- [30:44]
D
Cerement to follow that up. I think one thing that I did the first time I injected for a nail is I put it kind of a little too far up the tibia when I was doing a TTC nail. And so you kind of all sudden have a whole bunch at the tip of the nail. And so, you know, that's where the toucan helps or the other cannulas where you can kind of inject it in spots and work your way down. And that just that little bit of a flush that you see on the X ray and is enough to know where you've put it, but it doesn't get in the way of visualizing anything else. And then that allows the nail to be coated throughout the length of the nail.
- [31:23]
E
Correct. And I think, you know, nice segue to talk about the toucan, but I've been using it as well for all my TTC nails as well as tibial nails, and I've used it a couple of times for femur infected nonunions. It just also makes you feel better that you're getting antibiotic right at the area where that fracture is not just coated by the nail, but even just more in that in there. So tips and tricks I've learned with that is loading up the cannula, the toucan, with the probe that's taken out from it with a plunger out, loading it up, emptying the entire syringe in there, and then use your plunger as the delivery tool. You'll see it right away on Flora whenever you are injecting the whole ceremon into your toucan cannula. But it's not your star. Seeing it is with the plunger. And then as you said, making sure that you don't go too fast with that plunger right away as you're in the deepest part, or I guess the most proximal or distal part from your nail so that you make sure you coat the whole bone and not just putting everything at the tip of the nail.
- [32:24]
B
Man, you guys gave some excellent gems of technique tips there. The podcast listeners just learned years and years of experience from y' all in 10 minutes on some technique tips and just very valuable. I appreciate some of those things. I learned some things tonight just listening to you. So I appreciate it and I know both of you guys have a robust practice that takes care of these kinds of patients. Here in Charlotte. It's busy. Victor, he did his fellowship here. He knows it's a. It's pretty, pretty busy here with the pathology. We do have a multidisciplinary approach with the trauma team. And, and the trauma team does a great job using this with their open fractures, infected nonunions. You know, this paper, along with my experience to Victor's point, abused it in femurs, tibias, and TTCs. And they did talk about, you know, specifically using it for open fractures, but also infected non unions. And so again, you have an active infection. And so if you have a nonunion that's due to an infection, you do the standard hardware removal debridement. A lot of these patients would get staged with either X fixes or antibiotic nail that was just a pure antibiotic nail, made a chest tube. And then you got to come back, remove that, hope it doesn't break. You got to put it over a guide wire. Then you put a new. A new titanium nail with maybe the PMA around it to Victor's point. You got to downsize it. And then you got to take that out. If you take that out, the PMMA fractures, and now you got broken PMMA in the canal. That's a nightmare. And then you got to finally put the new nail in. And so now that patient's gone through three, four or five surgeries, maybe an X fix or a thin wire frame when using these techniques, maybe one or two surgeries. And the technique tips that both Kristen and Victor mentioned are absolute things that people need to take into account and use in practice that will save you a lot of pain and time. And then they mentioned the toucan, and I'm glad they did. We're going to talk about that. And so that's been a great add to our practices. You heard them both mention how they use it in their practice to be able to deliver the ceramic G down the canal. The plunger trick that Victor talked about is crucial to using all the product and then getting it to the right spot. And then I think unless anyone has any more comments about that paper or the toucan, I was just going to kind of maybe just take a quick little divergence from these two papers and just talk about. Does anyone have any experience or use or comments on the use of Cerament G with the use of 3D printed cages or total ankle replacement? I use Ceramen G today for both the 3D cage and a Infected total ankle. So anyone want to kind of talk about that?
- [35:16]
D
Well, I have a question for you, Kent. In your infected total ankle, did you then revise the infected total ankle in a single stage using Ceremon or was this coming back after taking it all out, putting an antibiotic cement spacer in there and then waiting six to eight weeks after antibiotics and then coming back the latter.
- [35:39]
B
So it wasn't a single stage, it was ankle out antibiotics, spacer in PICC line, come back new ankle in with.
- [35:47]
D
Ceramic G. So do you think that with the data we're seeing in papers like this, I believe, you know, we're not in the hip and knee world, but they are doing some of this with hip and knee. Do you think you, you're going to get to a point where you can use ceramic G to single stage and infected total ankle, A full washout, chlorhexidine wash, clean out any infected bone and then revise the total ankle and then as you insert the implants, you're placing cerumen in there for the bone.
- [36:19]
B
I do, I do think that that's a possibility. I think if it's not, you know, as long as it's like mssa, not MRSA and maybe not some other bad organisms that are bad patient situation, not just their comorbidities, but the clinical story. Was there a primary total ankle two months ago or two years ago? Did you do it? Did somebody else do it? Did they have a chronic wound for three months post op that kind of got ignored. And you know, so there are some factors that kind of goes into the art of medicine, but I do think there are going to be patients that we can. To your point, the total knee and hip guys and ladies are doing that. Now. The ankle is a little bit of a different soft tissue envelope than hip and knee. Definitely the hip. And we do have some things to, to worry about that they don't have to worry about. And, but you know, on the contrary, our soft tissue envelope can't take much. And so to your point, if we could do it in single stage, that would be great because going through that anterior incision 2, 3, 4 times, you're rolling the dice a lot. And so I do think that in the right patient population, a single stage using ceramic G, I would never do it without it has, has some legs.
- [37:32]
D
Yeah, I agree with you there. I think, you know, there's a whole variety of infected total ankles, from gross purulence to just kind of mildly infected. And I really think that in a few years we'll be doing a lot more single stage revisions than we're comfortable talking about now.
- [37:51]
B
Yeah.
- [37:52]
D
And I think Sarah McGee is going to play an important role in that. Regarding 3D cages, I know you do a lot of them, Kent. I do a decent amount as well. You know, there's a very porous structure in your 3D cage depending on what brand you're using. And they do provide an opportunity to store ceramen G in them. And you're in that area where, you know, you're worried about does metal create the glycocalyx for any old infection sticking around if you didn't get it in your debridement? Recently I started creating little silos, kind of stealing from the silo technique in the calcaneus and silo. When I designed the cages that I used, I get little silos put into them as well. I put 10cc's of ceramic G into one recently to just fill the cage and had some great video of it. And that I think helps me sleep more at night that I've created such a huge amount of local elution of gentamicin into the area where I'm trying to do this, you know, limb salvage due to a critical bone defect. So all of my 3D cages, I'd say most of them deal with infection and. But even if they don't, but I would say most of them are due to infection that I can then go in and I like you did with your revision total ankle from an infection at the time of final fixation, which is the 3D cage and a TTC nail. The use of ceramn G is part of the protocol and I think it's paramount to improve our outcomes. I think decreases soft tissue issues because the risk of ongoing infection is significantly lower. I don't have any data. I just feel that in the last few years, once we started combining ceramn G with 3D cages, the limb salvage rates are improving even more. I think 3D cages made a big bump and now we got the next bump here with local delivery of antibiotics.
- [39:54]
E
Agree that has been my experience as well with managing some charcoal hindfoot infections whenever, you know, I've seen osteomyelitis destroy the talus and I don't have a lot of options left there. I've been doing the same thing, filling up those cages there as well as doing the intermediary debridement into the tibia for the TTC nail. So a little combination of both the I am nailing technique and coating the cage and I'VE seen some great results and I've been happy with it so far. So I have adopted it for all my cages as well. And those ankles, I've had a couple of infected ankles. I have to say. I have done those with two stage revisions. But when coming back for the revision afterwards with the concerns of any leftover osteomyelitis in there, after the six weeks of IV antibiotics, we all know you've been antibiotics, all your cultures are going to be negative, your markers are better, but there's always a concern that there's some infection left in there. So still do authority breathing. And whenever I use a stem implant, part of my approach is also putting some cerements in the canal as well, where the stem implant is going to go to. Makes me sleep better at nights as well. That infection is going to be under control.
- [41:05]
B
Yeah, that's great commentary on that. To your point, I actually, I learned using ceramic G on the cages from Victor. So, you know, he was a fellow here five years ago and now the student becomes a teacher. And so I appreciate that Victor to share that with me with your experience. And now I use it for all of my cages too, as Chris does. And it's. I can see a difference. You know, to yalls point, these are very challenging clinical problems and this is the last ditch effort for a lot of these patients. And you have a massive bone defect filled with a 3D printed cage that doesn't work. Its amputation is usually the next stage. These patients have a history of infection and high risk for infection. And putting the ceramen g in and around the cage and in the bone bed as well and up the canal. A lot of These patients are TTCs with these cages. So use the toucan up to canal. You put the ceramic G around the cage in the cage. I love the silo trick. And you know, you almost can't overdo it here. So those cases are all hands on deck when it comes to infection control and biology and you know, 3D printed designs and hindford fixation.
- [42:20]
E
So.
- [42:21]
B
And so with that, I mean, I think we've had an awesome commentary on the two papers. We talked about Toucan. We talked about our clinical experience and understanding of the product and ended up with a little bit of discussion on 3D cages and total ankle experience. You know, I think we've kind of hammered home that overall experience, our belief in the product and a lot of case examples. Do either y' all have maybe one case example that comes to mind either, you know, recently or even A couple years ago, that was maybe your aha moment. It made a big change. The patient had five debridements, never got better, and finally you put ceramic in and boom, they clear the infection. Anything like that to kind of just end the podcast with.
- [43:09]
E
Yeah, I've had a few of those hurrah moments, especially in the beginning of practice when patients were coming because they wanted to avoid an amputation and they pretty much were told several times, no, this is the only thing you have left. And we've gone and addressed infection by just reaming the canal. Reaming. Do a lot of forefoot infections as well. And sometimes, you know, a toe amputation is not that big of a deal. We know that anyone with a toe amputation can be very likely to have higher level amputations. For any forefoot amputation, you're a 10 to 50% chance if you're a diabetic of having an additional amputation at that point. So, you know, even if we're talking about limb salvage in terms of legs, I think even toes matter, transmits matter, all that matters. So I've had a couple of patients in the beginning of my career that it really meant a lot when they were coming in saying, you know, I really don't want to lose this toe. I really don't want to have a transmit amputation. And we went in there, debrided the bone, put the ceremon in their single stage procedure, and voila, everything healed. Infection was well controlled. And that was after they spent, you know, a year and doing oral antibiotics, IV antibiotics, wound care, and all it needed was one debridement with cerumen for that to work. And ever since then, I was a believer of the single stage procedure.
- [44:20]
B
That's great.
- [44:22]
D
Yeah, I agree. I think I remember when the rep kept trying to get me to use it. Try to get it approved at our hospital, and I'll give you a free use or two. You know, why don't you try it? So, you know, we're the tertiary center for basically the northern half of California, which is quite a long ways. And so we get a lot of stuff from out in places that you've never heard of. And I remember getting a string of infections from a guy who was trying to put total ankles in people up north. And these were bad. I mean, one guy came in, he had multiple holes with pus draining out and had not really properly been managed. So, you know, we got to go back to the fundamentals. Take everything out, wash it out. This was going to be A staged. But, you know, there was infected navicular, there was infected tibia, infected tail. Everything was bad. And I just remember he said, just start putting it in that infected bone everywhere and then close those skin holes that you can. And I just remember that everything closed up, everything healed. And that goes to what the guys at the bone infection unit say is once that infection's gone, everything starts healing. The bone heals, the wound heals, the tissues granulate in. And sure enough, I saw that. So then it was kind of, okay, let's start trying it more places. And I think as you start to use it more and kind of test it out, you do see that it does work. And that what the data shows and what the research shows is easy to replicate in your practice, not just only in their practice.
- [45:57]
B
That's a fantastic summary there and good conclusion. I'll end it with. You know, some of these patients still unfortunately go on amputation. And to Victor's point, you know, it might be a toe, might be a ramp or transmed or below or even above knee amputation. I don't know how in Charlotte we do all the above knee amputations pretty much, but we do, even though we're Finn ankle docs. But it's kind of weird, but in fact, Victor, I remember us doing one when I was a massive BMI guy. Just got.
- [46:24]
E
I still have nightmares about that.
- [46:26]
B
Yeah, it's. I totally forgot about it to right now. Oh my gosh, I just had a flashback literally of that case. Like, that guy's leg was massive. But so if, you know, if the patient ends up getting an amputation. I started doing this about a year and a half ago during the case. One of my current fellows at the time was like, well, you know, you love Ceremony G so much. It works so well. Why don't we put it, you know, when we're doing the amputation too. So now if I do a ray amp the single, inject it up, you know, the first metatarsal or the second whatever raid fifth rate, injected in the metatarsal. If I do a tma, I injected all five. If I do a bk, I put it up to tibial canal and AK up to femoral canal. And so all these patients have, you know, active infection, wound complications. They're all poor host and, you know, their amputation is going to have a complication whether it's a wound distance or an infection. And if you can take infection off the block, at least you're just dealing with a wound problem versus an infected wound. So you know, which everything we're doing we're talking about tonight, it's limb salvage, but sometimes it doesn't work and it ends up with amputation and still I use ant serum G in those cases as well. So anyhow, I think if that was an amazing discussion and I love the commentary. I love Yalls experience and technical pearls and technique tips and the breakdown of those two articles. The listeners of this AFS podcast are in for a treat and and will learn a lot. So I appreciate Yalls clinical insight and sharing with us your experience, taking time to do this and appreciate Bone Support and their support of our society and for our society to have this venue for us to be able to do these podcasts that can be then, you know, tapped into by the members of our society and they can learn from us and think about how to incorporate this into the practice. Whether they're at home or maybe driving down the road, they can listen to this podcast. So it's a great tool for us to have. And again, thanks to AFS and thanks to Bone Support for allowing this to Happen. Thanks to Dr. Anciano, thanks to Dr. Krulin and I appreciate Yalls time and hope everybody has a good evening.
- [48:38]
D
Of course.
- [48:38]
E
Thank you so much for having me. It's been a pleasure and I'm glad that I'm not the only one struggling with all these tough cases, but looking forward to coming up with better ways to deal with too. It's nice to hear your guys's perspective on it. And thank you, Bone Support, for having us.
- [48:56]
D
Yeah, thank you, Bone Support. Thank you, Kent. Thank you, Victor. It was a great little conversation and I hope other people can learn from this.
- [49:04]
A
Thank you for listening to the AOFAS Ortho Podcast, a Convey Med production. To learn more about joining our dynamic community of highly skilled orthopedic specialists, visit aofas.org.